WO2003082091A3 - Integrated sample testing meter - Google Patents

Integrated sample testing meter Download PDF

Info

Publication number
WO2003082091A3
WO2003082091A3 PCT/IB2003/001844 IB0301844W WO03082091A3 WO 2003082091 A3 WO2003082091 A3 WO 2003082091A3 IB 0301844 W IB0301844 W IB 0301844W WO 03082091 A3 WO03082091 A3 WO 03082091A3
Authority
WO
WIPO (PCT)
Prior art keywords
test strip
blood
sample
testing meter
puncture site
Prior art date
Application number
PCT/IB2003/001844
Other languages
French (fr)
Other versions
WO2003082091A2 (en
Inventor
Alun Wyn Griffith
Keith May
Andrew Stephen Diston
Nicholas Andrew Drought
Donna Joy Wilson
Original Assignee
Inverness Medical Ltd
Alun Wyn Griffith
Keith May
Andrew Stephen Diston
Nicholas Andrew Drought
Donna Joy Wilson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inverness Medical Ltd, Alun Wyn Griffith, Keith May, Andrew Stephen Diston, Nicholas Andrew Drought, Donna Joy Wilson filed Critical Inverness Medical Ltd
Priority to AT03719025T priority Critical patent/ATE556655T1/en
Priority to AU2003223055A priority patent/AU2003223055B2/en
Priority to KR1020037016471A priority patent/KR100948006B1/en
Priority to CA2448584A priority patent/CA2448584C/en
Priority to EP03719025A priority patent/EP1492446B1/en
Priority to IL159051A priority patent/IL159051A/en
Priority to JP2003579640A priority patent/JP2005521452A/en
Publication of WO2003082091A2 publication Critical patent/WO2003082091A2/en
Publication of WO2003082091A3 publication Critical patent/WO2003082091A3/en
Priority to HK05103781.2A priority patent/HK1070806A1/en

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48757—Test elements dispensed from a stack
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A61B5/150198—Depth adjustment mechanism at the proximal end of the carrier of the piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Abstract

An integrated sample testing meter, for instance for measuring blood, comprising a puncture means, a sensor and a test strip cartridge disposed in a single modular housing. The test strip cartridge includes a stack of test strips suitable for performing an electrochemical or photometric analysis of a blood sample. The integrated test system automatically dispenses and positions a test strip and forms a puncture site. Blood is transferred to the test strip from the puncture site and the sensor automatically analyzes the blood sample after the test strip collects the sample from the puncture site.
PCT/IB2003/001844 2002-04-02 2003-04-02 Integrated sample testing meter WO2003082091A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
AT03719025T ATE556655T1 (en) 2002-04-02 2003-04-02 INTEGRATED TEST DEVICE FOR SAMPLES
AU2003223055A AU2003223055B2 (en) 2002-04-02 2003-04-02 Integrated sample testing meter
KR1020037016471A KR100948006B1 (en) 2002-04-02 2003-04-02 Integrated sample testing meter
CA2448584A CA2448584C (en) 2002-04-02 2003-04-02 Integrated sample testing meter
EP03719025A EP1492446B1 (en) 2002-04-02 2003-04-02 Integrated sample testing meter
IL159051A IL159051A (en) 2002-04-02 2003-04-02 Integrated sample testing meter
JP2003579640A JP2005521452A (en) 2002-04-02 2003-04-02 Integrated sample tester
HK05103781.2A HK1070806A1 (en) 2002-04-02 2005-05-04 Integrated sample testing meter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0207610A GB2388898B (en) 2002-04-02 2002-04-02 Integrated sample testing meter
GB0207610.7 2002-04-02

Publications (2)

Publication Number Publication Date
WO2003082091A2 WO2003082091A2 (en) 2003-10-09
WO2003082091A3 true WO2003082091A3 (en) 2003-12-24

Family

ID=9934115

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/GB2003/001438 WO2003083469A2 (en) 2002-04-02 2003-04-02 Integrated sample testing meter
PCT/IB2003/001844 WO2003082091A2 (en) 2002-04-02 2003-04-02 Integrated sample testing meter

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/GB2003/001438 WO2003083469A2 (en) 2002-04-02 2003-04-02 Integrated sample testing meter

Country Status (14)

Country Link
EP (3) EP1950562B1 (en)
JP (2) JP2005522243A (en)
KR (1) KR100948006B1 (en)
CN (2) CN100419424C (en)
AT (1) ATE556655T1 (en)
AU (2) AU2003217051B2 (en)
CA (3) CA2448584C (en)
ES (2) ES2624738T3 (en)
GB (1) GB2388898B (en)
HK (2) HK1060039A1 (en)
IL (2) IL164380A0 (en)
RU (1) RU2360248C2 (en)
TW (1) TWI315400B (en)
WO (2) WO2003083469A2 (en)

Cited By (90)

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